Toxicology SIG

Our mission statement:

To provide a forum to discuss the statistical issues involved in Regulatory and Investigative Toxicology.

Our membership consists of statisticians at CROs, pharmaceutical companies and academia who are working in preclinical areas such as:

- Acute Tox
- General Tox
- Toxicokinetics
- Repro Tox
- Genetic Tox
- Immuno Tox
- Toxicogenomics
- Histopathology
- Safety Pharmacology
- Carcinogenicity

We discuss topics ranging from Dog Telemetry data analysis to Decision Trees, from Bayesian methods to dealing with irate study directors, and no have a list of over 40 affiliates on our e-mail distribution list.
Join our mailing list by e-mailing this address with brief details of the field(s) you are working in.


In October 2015 we ran our latest Workshop, at Heathrow. The agenda focused on five hot topics in Toxicology: 

  • Analysis of Large Datasets
  • Experimental Design
  • Anti-drug Antibody assays (cut point determination)
  • Benchmark Dose Approach
  • Carcinogenicity study update

Since our inauguration in 2006 we have run these workshops approximately every 18 months, with ad hoc webinar meetings held during the year. We are running the next workshop on 14th and 15th March 2017 at the Crowne Plaza Hotel, Heathrow, UK. To register click here.


Recent Activity

We recently sent out a questionnaire asking about interest in topics for our workshop. The top five topics of interest were:

  1. Repeated measures: In general for all data types (Body weight, activity data, etc.)
  2. Historical Control Data ranges/outliers/control charts
  3. Outlier determination
  4. Carcinogenicity studies:
    - How to deal with treated groups sacrificed earlier than control
    - Impact on label of running transgenic instead of 2 x 2 year studies
  5. How do we empower our scientists to do some routine analyses, whilst also ensuring quality of results?


Latest News

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Workshop 2017

EventsFuture Events

  • Expert Working Group on Confidentiality of Interim Results - Dates: 11 May, 2017

    The PSI/EFSPI expert working group on Confidentiality of Interim Results are planning to meet face to face on 11 May.
  • Estimating Sample Sizes in Clinical Trials - Dates: 28 – 29 Jun, 2017

    The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will be highlighted how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.

Medical Statistician / Senior Medical Statistician


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Director, Statistics



Associate Director, Statistics Team leader - Early Clinical Development



Early Clinical Development – various levels



Biostatistics Head of Department



Principal Statistician – Centralised Statistical Monitoring



Clinical Trial Design Methodology Expert - Statistical Innovation Team